Rich Countries Signed Away a Chance to Vaccinate the World

In the coming days, a patent will finally be issued on a five-year-old invention, a feat of molecular engineering that is at the heart of at least five major Covid-19 vaccines. And the United States government will control that patent.

The new patent presents an opportunity — and some argue the last best chance — to exact leverage over the drug companies producing the vaccines and pressure them to expand access to less affluent countries.

The question is whether the government will do anything at all.

The rapid development of Covid-19 vaccines, achieved at record speed and financed by massive public funding in the United States, the European Union and Britain, represents a great triumph of the pandemic. Governments partnered with drugmakers, pouring in billions of dollars to procure raw materials, finance clinical trials and retrofit factories. Billions more were committed to buy the finished product.

But this Western success has created stark inequity. Residents of wealthy and middle-income countries have received about 90 percent of the nearly 400 million vaccines delivered so far. Under current projections, many of the rest will have to wait years.

to help an Indian company produce about 1 billion doses by the end of 2022 and his administration has donated doses to Mexico and Canada. But he has made it clear that his focus is at home.

“We’re going to start off making sure Americans are taken care of first,” Mr. Biden said recently. “But we’re then going to try and help the rest of the world.”

Pressuring companies to share patents could be seen as undermining innovation, sabotaging drugmakers or picking drawn-out and expensive fights with the very companies digging a way out of the pandemic.

As rich countries fight to keep things as they are, others like South Africa and India have taken the battle to the World Trade Organization, seeking a waiver on patent restrictions for Covid-19 vaccines.

as part of their vaccine diplomacy. The Gamaleya Institute in Moscow, for example, has entered into partnerships with producers from Kazakhstan to South Korea, according to data from Airfinity, a science analytics company, and UNICEF. Chinese vaccine makers have reached similar deals in the United Arab Emirates, Brazil and Indonesia.

Canada to Bangladesh say they can make vaccines — they just lack patent licensing deals. When the price is right, companies have shared secrets with new manufacturers in just months, ramping up production and retrofitting factories.

pressured Johnson & Johnson to accept the help and is using wartime procurement powers to secure supplies for the company. It will also pay to retrofit Merck’s production line, with an eye toward making vaccines available to every adult in the United States by May.

Despite the hefty government funding, drug companies control nearly all of the intellectual property and stand to make fortunes off the vaccines. A critical exception is the patent expected to be approved soon — a government-led discovery for manipulating a key coronavirus protein.

This breakthrough, at the center of the 2020 race for a vaccine, actually came years earlier in a National Institutes of Health lab, where an American scientist named Dr. Barney Graham was in pursuit of a medical moonshot.

For years, Dr. Graham specialized in the kind of long, expensive research that only governments bankroll. He searched for a key to unlock universal vaccines — genetic blueprints to be used against any of the roughly two dozen viral families that infect humans. When a new virus emerged, scientists could simply tweak the code and quickly make a vaccine.

In 2016, while working on Middle East Respiratory Syndrome, another coronavirus known as MERS, he and his colleagues developed a way to swap a pair of amino acids in the coronavirus spike protein. That bit of molecular engineering, they realized, could be used to develop effective vaccines against any coronavirus. The government, along with its partners at Dartmouth College and the Scripps Research Institute, filed for a patent, which will be issued this month.

another virus when the outbreak in China inspired his team to change focus. “We just flipped it to coronavirus and said, ‘How fast can we go?’” Dr. Graham recalled.

filed such a lawsuit in 2019 against the drugmaker Gilead over H.I.V. medication.

being lured to the United States.

“We funded the research, on both sides of the Atlantic,” said Udo Bullmann, a German member of the European Parliament. “You could have agreed on a paragraph that says ‘You are obliged to give it to poor countries in a way that they can afford it.’ Of course you could have.”

In May, the leaders of Pakistan, Ghana, South Africa and others called for governments to support a “people’s vaccine” that could be quickly manufactured and given for free.

They urged the governing body of the World Health Organization to treat vaccines as “global public goods.”

Though such a declaration would have had no teeth, the Trump administration moved swiftly to block it. Intent on protecting intellectual property, the government said calls for equitable access to vaccines and treatments sent “the wrong message to innovators.”

World leaders ultimately approved a watered-down declaration that recognized extensive immunization — not the vaccines themselves — as a global public good.

grant language requiring equitable access to vaccines. As leverage, the organization retains some right to the intellectual property.

Dr. Slaoui, who came to Warp Speed after leading research and development at GlaxoSmithKline, is sympathetic to this idea. But it would have been impractical to demand patent concessions and still deliver on the program’s primary goals of speed and volume, he said.

“I can guarantee you that the agreements with the companies would have been much more complex and taken a much longer time,” he said. The European Union, for example, haggled over price and liability provisions, which delayed the rollout.

In some ways, this was a trip down a trodden path. When the H1N1 “swine flu” pandemic broke out in 2009, the wealthiest countries cornered the global vaccine market and all but locked out the rest of the world.

Experts said at the time that this was a chance to rethink the approach. But the swine flu pandemic fizzled and governments ended up destroying the vaccines they had hoarded. They then forgot to prepare for the future.

For months, the United States and European Union have blocked a proposal at the World Trade Organization that would waive intellectual property rights for Covid-19 vaccines and treatments. The application, put forward by South Africa and India with support from most developing nations, has been bogged down in procedural hearings.

“Every minute we are deadlocked in the negotiating room, people are dying,” said Mustaqeem De Gama, a South African diplomat who is involved in the talks.

But in Brussels and Washington, leaders are still worried about undermining innovation.

During the presidential campaign, Mr. Biden’s team gathered top intellectual property lawyers to discuss ways to increase vaccine production.

“They were planning on taking the international view on things,” said Ana Santos Rutschman, a Saint Louis University law professor who participated in the sessions.

Most of the options were politically thorny. Among them was the use of a federal law allowing the government to seize a company’s patent and give it to another in order to increase supply. Former campaign advisers say the Biden camp was lukewarm to this proposal and others that called for a broader exercise of its powers.

The administration has instead promised to give $4 billion to Covax, the global vaccine alliance. The European Union has given nearly $1 billion so far. But Covax aims to vaccinate only 20 percent of people in the world’s poorest countries this year, and faces a $2 billion shortfall even to accomplish that.

Dr. Graham, the N.I.H. scientist whose team cracked the coronavirus vaccine code for Moderna, said that pandemic preparedness and vaccine development should be international collaborations, not competitions.

“A lot of this would not have happened unless there was a big infusion of government money,” he said.

But governments cannot afford to sabotage companies that need profit to survive.

Dr. Graham has largely moved on from studying the coronavirus. He is searching for a universal flu vaccine, a silver bullet that could prevent all strains of the disease without an annual tweak.

Though he was vaccinated through work, he spent the early part of the year trying to get his wife and grown children onto waiting lists — an ordeal that even one of the key inventors had to endure. “You can imagine how aggravating that is,” he said.

Matina Stevis-Gridneff and Monika Pronczuk contributed reporting.

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Where Europe Went Wrong in Its Vaccine Rollout, and Why

BRUSSELS — The calls began in December, as the United States prepared to administer its first batches of Covid-19 vaccine. Even then, it was clear that the European Union was a few weeks behind, and its leaders wanted to know what they could learn from their American counterparts.

The questions were the same, from President Emmanuel Macron of France, President Ursula von der Leyen of the European Commission, and Alexander De Croo, the prime minister of Belgium.

“How did you do it?” Dr. Moncef Slaoui, the United States vaccine czar, recalled them asking on the calls. “And what do you think we missed?”

Since then, the rollout gap between Europe and the United States has only widened, and some of the countries hardest hit early in the pandemic are facing a deadly third wave of infections. France, large parts of Italy, and other regions are back in lockdown. Roughly 20,000 Europeans die of Covid-19 each week.

temporarily halt the distribution of the AstraZeneca vaccine. Most of them resumed using it on Friday, after Europe’s top drug regulator vouched for its safety, but public confidence in the shot has been badly shaken.

Vaccine salvation remains, for now, still tantalizingly out of reach. Only about 10 percent of Europeans have received a first dose, compared with 23 percent in the United States and 39 percent in Britain.

There is no single culprit. Rather, a cascade of small decisions have led to increasingly long delays. The bloc was comparatively slow to negotiate contracts with drugmakers. Its regulators were cautious and deliberative in approving some vaccines. Europe also bet on vaccines that did not pan out or, significantly, had supply disruptions. And national governments snarled local efforts in red tape.

leaders pointing fingers over why some of the world’s richest countries, home to factories that churn out vast quantities of vaccine, cannot keep pace with other wealthy nations in injecting its people.

Compared with nearly all the rest of the world, the European Union is in an admirable position. Its leaders say it remains feasible to vaccinate 70 percent of the Continent by this summer. The bloc has ordered enough doses to fully vaccinate its population at least three times, to the consternation of countries that will wait years for full coverage.

But Europeans are stung, especially, to see Britain’s rollout going so well after the country exited the bloc. Everyone wants to know why the E.U. has not triumphed.

The European Union trailed the United States and Britain from the start.

Washington had already spent billions on clinical trials and manufacturing by the time Europe decided to pool its resources and negotiate as a bloc. In mid-June, the European Commission, the bloc’s executive branch, announced a joint vaccine purchase with a $3.2 billion pot.

$10 billion budget. European officials say it’s unfair to compare the two figures because neither amount is a complete picture of all the money spent on vaccines. But there is no dispute that in Washington, officials had decided that money was no object if vaccines could avert the economic cost of a lockdown. Europe, on the other hand, was on a tight budget, so its negotiators chased cheaper doses.

“Pricing has been important since the beginning,” Sandra Gallina, the E.U.’s main vaccine negotiator, told lawmakers in February. “We are talking about taxpayers’ money.”

AstraZeneca has slashed its delivery plans, telling European leaders that it would hand over 100 million fewer doses by the middle of the year, according to the commission’s president, Ms. von der Leyen.

Only one in five French people now trust the AstraZeneca vaccine, according to a poll by the Elabe Institute published Tuesday.

Now Europe is striking a more aggressive tone about protecting its interests. Italy blocked a small shipment of AstraZeneca vaccines to Australia earlier this month. Ms. von der Leyen upped the ante this week, threatening to use an emergency mechanism, last used during the 1970s oil crisis, that would allow the bloc to seize production of vaccines.

“It is hard to explain to our citizens why vaccines produced in the E.U. are going to other countries,” Ms. von der Leyen said.

Early this month, Toon Vanagt, a Belgian tech entrepreneur, accompanied his 77-year-old father to a vaccination center north of Brussels. Mr. Vanagt, 47, was not eligible for the vaccine himself, but a worker there offered him a leftover shot, which he gladly accepted.

software companies have rushed to link patients with doses that would otherwise expire. But in Belgium, when Mr. Vanagt tweeted that he had been vaccinated, it became a mini scandal. Health officials rebuked the vaccine center, which quickly apologized: “A minor communication problem, very quickly rectified.”

Belgium’s rollout is one example of the Continent’s rigid approach to following vaccination guidelines. In a country where nursing home infections led to one of the highest per capita death tolls, the policy was intended to strictly prioritize the neediest residents.

Many European countries are also stockpiling doses to guarantee that everyone who receives a first injection will receive the second dose on time. The United States and Britain have been more flexible, erring on the side of giving more first injections.

“In the U.S., there is a much more flexible, liberal system and you just vaccinate people who come along. Same in the U.K. And it can go quicker. Here it is quite regulated,’’ said Steven Van Gucht, the Belgian government’s top virologist, who said it was too soon to know which system is better.

Administrative hiccups have exacerbated the problems. In Frankfurt, Elke Morgenstern was escorted out of a vaccine center because she enrolled using the wrong online application. “It was embarrassing,” said Ms. Morgenstern, adding that she qualified for a vaccine because of a pre-existing condition.

Because of the AstraZeneca shortages, she cannot book another appointment before May.

“It is a catastrophe how they are handling things here,” she said.

In the Lombardy region of Italy, once the epicenter of the pandemic, the vaccination campaign got off to a slow start in part because the top health care official refused to marshal medical workers over the Christmas holidays. Technical difficulties worsened the problems at the region’s vaccination centers.

“Some sessions were empty,” said Paola Pedrini, the regional secretary general for Italy’s family doctors federation. “For some others, they called 900 people when they could only vaccinate 600.”

For all the problems, Dr. Slaoui said Europeans are in an admirable position. By the numbers, the Continent is about five weeks behind the United States, with vaccine supply expected to increase steadily. “It’s too late to have taken the first bite,” he said. “But they’re in a good place.”

Dr. Van Gucht, of Belgium, agreed. But he said European leaders will likely take nationalistic lessons from the past months.

“I think we relied a little bit too much on the free markets,” he said. “What you really need to do from the beginning is really make sure you produce the vaccines on your territory and that they’re destined for your own population.”

Jason Horowitz and Emma Bubola contributed reporting from Italy and Melissa Eddy from Berlin.

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